Bayer's Nexavar in FDA fast lane for thyroid cancer use

Bayer's Nexavar is one big step closer to a thyroid-cancer approval. The FDA put the drug on the priority-review fast track, which means Nexavar could have its new indication by February. It's a timely win for Bayer's development partner, Onyx Pharmaceuticals ($ONXX), which just agreed to a $10.4 billion buyout by Amgen.

It's not a huge new market--analysts see $200 million in additional sales--but it's a needy one. Nexavar would be pointed toward patients whose cancer has returned after surgery and radiation--patients whose treatment options are limited, and prognosis poor. Plus, adding indications one by one--small or not-so-small--is a common strategy for keeping sales growth coming, particularly in cancer. Nexavar, also known as sorafenib, is under study for several other groups of cancer patients.

The FDA submission is based on a trial presented at the American Society for Clinical Oncology meeting in June. Nexavar almost doubled progression-free survival, to a median of 10.8 months in patients treated with it, compared with 5.8 months in control patients. Bayer filed for FDA approval soon after.

Dr. Pamela Cyrus, VP and head of U.S. Medical Affairs for Bayer HealthCare's pharma division, hailed the chance for priority review. "This is an important milestone for sorafenib and the designation highlights the urgent need for new treatments for patients with this type of thyroid cancer who have limited or no treatment options," Cyrus said in a statement.

Now approved to treat liver and kidney cancer, Nexavar brought in €792 million last year, about $900 million. Its sales for the first half of this year amounted to €373 million, a bit less than the same period last year. So, new uses are key for continued growth. The thyroid cancer approval would be a help, but Bayer and Onyx had really hoped for a new indication in lung cancer, the third most common type of cancer in the U.S. That study fell short last year.

Meanwhile, Bayer continues to study Nexavar in other types of cancer. Two phase III breast cancer trials are ongoing, as is a study of Nexavar as an adjuvant treatment in liver and kidney cancer patients.